Shorter pelvic radiotherapy after surgery for cervical or endometrial cancer

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This randomized phase II trial compares hypofractionated whole pelvic radiotherapy to conventional postoperative radiotherapy in patients with cervical or endometrial cancer. Participants who have had surgery are assigned to either a shorter, higher-dose-per-session regimen or the standard, longer course, with the total radiation dose kept similar. The study will measure treatment-related toxicity, tumor control, survival, and quality of life to determine if the shorter schedule is non-inferior in safety and effectiveness. It aims to address treatment burden, access, and potential impacts on outcomes in diverse settings. Safety and efficacy data will help inform whether a shorter postoperative radiotherapy approach can be adopted more broadly.

Why it matters

Who can join: the full rules

Inclusion Criteria:

1. Pathologically proven carcinoma of the uterine cervix; and carcinoma and carcinosarcoma of uterine corpus
2. Hysterectomy (total abdominal hysterectomy, vaginal hysterectomy, total laparoscopic hysterectomy or radical hysterectomy) for cancer of the cervix or endometrium within 49 days prior to registration. Hence inadvertent surgery will be allowed for inclusion.
3. Indicated for adjuvant EBRT from multidisciplinary team discussion.
4. Non-metastatic stage according to FIGO 2018 for Cervical cancer and FIGO 2023 for Endometrial cancer and TNM guidelines from appropriate diagnostic workup 4.1 History/physical examination within 45 days prior to registration 4.2 CT/MRI/PET-CT of abdomen/pelvis demonstrating the absence of distant metastasis, performed pre- or post-surgery within 90 days prior to registration 4.3 Chest x-ray or chest CT (or a PET/CT) performed within 90 days prior to registration
5. Age ≥18 years old with informed consent

Exclusion Criteria:

1. Other primary malignancies except carcinoma in situ of the cervix and basal cell carcinoma of the skin
2. Small cell neuroendocrine cancer, melanoma, uterine sarcoma, and other rare cancers in the cervix and uterus
3. Metastatic disease beyond intervertebral disc L2/3 level
4. Previous pelvic or abdominal radiotherapy
5. Combination of preoperative chemotherapy or radiotherapy with surgery
6. Contra-indications to EBRT

Where it's running

• Siriraj Hospital
  Bangkok, Bangkok, Thailand Recruiting

Study contacts

• Study coordinator: Tissana Prasartseree, MD
• Email: tissana.p@gmail.com
• Phone: 66625246101

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.